The present invention relates to surgical devices, namely, a device for selectively holding and positioning a prosthetic heart valve for implantation.
A prosthetic heart valve is used to replace a native heart valve that is malformed, damaged, or otherwise unable to properly regulate blood flow through a heart. Typically, a prosthetic heart valve includes a generally annular, rigid ring supporting one or more leaflets. The leaflets open and close to regulate blood flow in one direction. The mitral and tricuspid valves function as "inflow" valves, i.e., regulate blood flow into the ventricles, thus preventing backflow into the auricles. The aortic and pulmonary valves function as "outflow" valves, i.e., regulate blood flow out of the ventricles, thus preventing backflow into the ventricles.
A valve holder is used by a surgeon to hold and position a prosthetic heart valve for attachment to the native valve annulus, and sometimes to turn the valve body after the valve is placed within the heart to orient the leaflets away from potential contact with surrounding tissue. Although a single type of prosthetic heart valve may be used for either inflow or outflow valve replacement, the valve holder must grasp the valve from the proper end of the valve, so that the leaflets are properly oriented (inflow or outflow) for the designated type of implantation. Also, prosthetic valves are manufactured in different sizes, allowing a surgeon to select the valve size which is closest to the size of the native annulus receiving the valve. The valve holder must be carefully manipulated by the surgeon in order to prevent any stress or damage to the valve leaflets.
Many prosthetic heart valves are provided with pre-attached, disposable valve holders. Consequently, the valve holder is matched with a valve for size and orientation. However, this configuration adds to the total cost of the valve and creates additional medical waste (the valve holder) which must be properly disposed. Also, the pre-attached valve holder predisposes the use of the valve as either an inflow or outflow valve, increasing the inventory of prosthetic valve/holder combinations a hospital carries.
Another holder configuration employs a single handle which may be coupled with one of three different attachments for various valve sizes. Refer generally to Morse, Dryen, et al., Guide to Prosthetic Cardiac Valves, Springer-Verlag, 1985. This configuration also has the drawback of the cost and inventory for each of the attachments.